Back to resultsThe Effects of Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure Regulation in Middle Aged and Older Adults (S31)
Primary Purpose
Hypertension, Dyslipidemias
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DASH diet counseling
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- male or female
- age 40-75
- BMI 25-40 kg/m2
- systolic blood pressure 120-160 mm Hg
- diastolic blood pressure <100 mm Hg
- non-diabetic, no acute illness
- not following vigorous exercise program
- urinary continence
Exclusion Criteria:
- age <40 or >75
- BMI <25 or >40 kg/m2
- systolic blood pressure <120 or >160 mm Hg
- diastolic blood pressure >100 mm Hg
- diabetic, acute illness
- following vigorous exercise program
- urinary incontinence
- current smoker
Sites / Locations
- Purdue University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Dietary Counseling
Arm Description
Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure
Outcomes
Primary Outcome Measures
Change in blood pressure
Secondary Outcome Measures
Change in blood lipids
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01696097
Brief Title
The Effects of Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure Regulation in Middle Aged and Older Adults
Acronym
S31
Official Title
The Effects of Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure Regulation in Middle Aged and Older Adults (S31)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if the source of dietary protein (pork or chicken/fish) as a part of the DASH diet affects blood pressure control in adults with high blood pressure.
Detailed Description
High blood pressure is a major risk factor for heart disease and stroke and affects 50 million people in the United States. Making healthy food choices, such as those in the DASH (Dietary Approaches to Stop Hypertension) Diet, has been shown to improve blood pressure control in people with high blood pressure. The purpose of this study is to determine if the source of dietary protein (pork or chicken/fish) as a part of the DASH diet affects blood pressure control in adults with high blood pressure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Dyslipidemias
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary Counseling
Arm Type
Other
Arm Description
Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure
Intervention Type
Behavioral
Intervention Name(s)
DASH diet counseling
Intervention Description
Comparison of protein source (chicken and fish vs. pork) as part of DASH diet on blood pressure regulation and blood lipids.
Primary Outcome Measure Information:
Title
Change in blood pressure
Time Frame
After 6 weeks of following DASH diet
Secondary Outcome Measure Information:
Title
Change in blood lipids
Time Frame
After 6 weeks of following DASH diet
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male or female
age 40-75
BMI 25-40 kg/m2
systolic blood pressure 120-160 mm Hg
diastolic blood pressure <100 mm Hg
non-diabetic, no acute illness
not following vigorous exercise program
urinary continence
Exclusion Criteria:
age <40 or >75
BMI <25 or >40 kg/m2
systolic blood pressure <120 or >160 mm Hg
diastolic blood pressure >100 mm Hg
diabetic, acute illness
following vigorous exercise program
urinary incontinence
current smoker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne W Campbell, Ph. D.
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26063693
Citation
Sayer RD, Wright AJ, Chen N, Campbell WW. Dietary Approaches to Stop Hypertension diet retains effectiveness to reduce blood pressure when lean pork is substituted for chicken and fish as the predominant source of protein. Am J Clin Nutr. 2015 Aug;102(2):302-8. doi: 10.3945/ajcn.115.111757. Epub 2015 Jun 10.
Results Reference
derived
Links:
URL
http://dashdiet.org/
Description
DASH eating plan info
Learn more about this trial
The Effects of Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure Regulation in Middle Aged and Older Adults
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